The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart
Wroclaw Medical University
100 participants
May 10, 2024
INTERVENTIONAL
Conditions
Summary
Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.
Eligibility
Inclusion Criteria4
- primary PVI
- paroxysmal atrial fibrillation
- sinus rhythm at the admission
- participant meets clinical criteria for PVI
Exclusion Criteria9
- LA diameter \<38 mm or \>50 mm
- LVEF \<40%
- intrinsic sinus node disease
- advanced atrioventricular block (PR interval \>300 ms, II or III degree AV block)
- previous cardioneuroablation procedure
- pregnancy
- contraindications to anticoagulation treatment
- any other clinical contraindications to PVI
- known atropine intolerance
Interventions
all applications in all PVs are done with 28 mm balloon
first applications in LSPV and RSPV are done with 31 mm balloon
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06053606